A doctor struggles with the lack of data surrounding the Covid-19 vaccine and pregnancy.
The morning after the Food and Drug Administration approved the emergency use authorization of the first coronavirus vaccine, I awoke to a message from my hospital asking me to sign up for an appointment to get vaccinated.
It brought tears to my eyes. As a primary care doctor, I haven’t exactly been on the front lines of the Covid-19 fight, but it’s upended my life and the lives of my patients. With the vaccine’s approval — and now a second one — we finally have an end in sight. Within hours, my colleagues were all texting each other, abuzz with the excitement of scheduling their vaccine appointments.
But I quickly learned I have an impossible choice ahead of me.
I am pregnant, and all of the clinical trials on Covid-19 vaccines excluded pregnant people. This is no surprise: pregnant people are frequently left out of clinical research because of the complexity of pregnancy, including concerns about potential harm to the fetus. That leaves us with little data to help us make decisions about medications and vaccines.
Instead we’re on our own, winging it during an already vulnerable time. And as I care for a ballooning number of coronavirus-positive patients each day, my decision about the vaccine seems more urgent than ever.
The news of my pregnancy was a joyful moment for my family in a difficult year, but Covid-19 has been a terrifying backdrop. I practice in Camden, N.J., and our community has been hard-hit. Infections are soaring above the springtime peak. My inbox contains positive case after positive case.
My patients are the most essential of essential workers — home health aides, warehouse workers, janitors — still, even after all we’ve learned this year, with little job security, minimal paid sick leave and inadequate personal protective equipment. And as my patients get exposed to the virus, so do I.
The data on coronavirus infection during pregnancy are not reassuring. Pregnant people who get the virus seem to have a higher risk for severe symptoms and complications, and there also may be a small increased risk of preterm birth. Each day I walk into my clinic, I ask myself, “Will this be the day I get it?”
The early news about the efficacy of the vaccines was thrilling. But there has been little data on how the vaccine affects pregnant people. No pregnant patients were enrolled in the early trials, although some people got pregnant during the course of the study. Researchers are monitoring them to see how they do.
According to Ruth Faden, a Johns Hopkins bioethicist who studies vaccine policy, the reluctance to include pregnant research subjects in clinical trials has a long history.
“There’s an inertia that’s set in,” she told me. Studying pregnant people requires extra effort in safe study design and recruitment efforts, so rather than do the hard work, she says, pregnant women are often just excluded altogether.
“It’s an ethically complex situation,” she added. “Pregnancy is like nothing else. Anything you do to a pregnant woman also has a chance of affecting the developing offspring.”
Researchers estimate we have adequate data on the risk of birth defects in less than 10 percent of medications approved by the Food and Drug Administration since 1980. That means any time a pregnant person thinks about using a medication or vaccine, she might feel like she’s making a decision at random, without any rigorous information to guide her.
That’s certainly how I feel right now. My medical training taught me to respect my patients’ autonomy; I see my job as guiding them through confusing medical information and helping them make decisions, not making decisions for them. Patient autonomy is a primary value in medicine.
I was glad to see that the F.D.A. left the choice of whether or not to get the Covid-19 vaccine up to pregnant women, rather than excluding us from eligibility altogether. For a pregnant nursing home aide, or a pregnant intensive care unit nurse, the risk of getting Covid-19 might be greater than the risk of any potential vaccine side effects.
This isn’t a theoretical exercise for hundreds of thousands of health care workers. Women make up an estimated 76 percent of the health care work force, many of us of childbearing age. I have text message chains with several pregnant and breastfeeding physician friends, all of us trying to sort through the limited information we have.
But without any data to guide me, my autonomy to make the decision doesn’t feel as meaningful. The American College of Obstetricians and Gynecologists offered this wildly unsatisfying recommendation: “Covid-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination.” The Centers for Disease Control and Prevention issued similarly noncommittal guidance: “Health care personnel who are pregnant may choose to be vaccinated.” Both are a far cry from the two organizations’ enthusiastic support for the flu vaccine in pregnancy, for example.
So it’s up to me and my nurse midwife, both of us smart clinicians, but not vaccine experts. I asked her what she thought, and she told me, “Honestly, I have no idea.”
I try to weigh the costs and benefits: I care for positive patients, but it’s not as if I’m an I.C.U. doctor. Many vaccines are safe in pregnancy — I gladly got my flu shot early on — but other vaccines aren’t. How can I weigh the costs and benefits if I don’t know what the costs are?
The two vaccines that have now been approved use a novel messenger RNA technology that has not been studied in pregnancy. It’s possible the mRNA and the bubble it travels in, made of lipid nanoparticles, could cross the placenta, according to Dr. Michal Elovitz, a preterm labor researcher and obstetrician at the University of Pennsylvania. This might, in theory, cause inflammation in utero that could be harmful to the developing fetal brain.
Or, the lipid nanoparticles might not cross the placenta, Dr. Elovitz says. It’s also possible the new vaccines could be totally safe in pregnancy, like the flu shot. We just don’t have the data yet.
“To avoid having pregnant people guess, we should be advocating for more preclinical and clinical research focused on pregnant patients,” she told me.
My bottom line: If I have the chance, I’ll gladly enroll in a clinical trial of a Covid-19 vaccine for pregnant people. It’s a choice that feels much more grounded in science than trying to figure this out on my own, because I’d be making it alongside the expertise of the scientists designing the trial.
I’d feel reassured that experts in immunology and pregnancy physiology had determined the safest trimester to get the vaccine. I’d feel reassured that they had done that using evidence from animal studies, and I’d feel reassured by the ethics board that approved the trial. It wouldn’t be a risk-free decision, but it would make me feel like it wasn’t a totally reckless one.
Until then, I’ll take care of my patients with my mask, my face shield, and my gloves, hoping I don’t get infected, thinking every day about my health and the health of my baby.
Dr. Mara Gordon is a family physician in Camden, N.J.
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